Comparison of the Efficiency of Intra-uterine Insemination and in Vitro Fertilization in Women Over 37 Years

NCT ID: NCT02001870

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2019-07-31

Brief Summary

As age increases the chances for a woman to become pregnant decrease as well spontaneously as through assisted reproductive technologies (ART). For the treatment of unexplained infertilities two techniques can be used: intra-uterine insemination (IUI) and in vitro fertilization (IVF). The aim of the present study is to compare the efficiency in term of delivery rate of IUI and IVF in couples in whom the female age is over 37 years.

Detailed Description

IUI can be used to treat infertility when tubes are normal, with no severe endometriosis and enough motile spermatozoa can be inseminated. In these cases IUI are usually performed (4 to 6 attempts) and IVF only in case of IUI failure. Indeed if the pregnancy rate per attempt is higher with IVF, IUI can be performed more frequently (6 times a year vs. 2 for IVF) so that the pregnancy rates after one year of treatment are close. When female age is over 37 years, some ART centers prefer to perform directly IVF, since chances of pregnancy decreases with time. However there is no argument in the literature in favor as well as in disfavor for such an attitude. Indeed the delivery rates after one year treatment with IUI or IVF are not known in this population. Therefore we propose a multicentric randomized controlled trial comparing IUI and IVF in women over 37 with unexplained infertility. Couples will be randomly allocated to IUI or IVF during one year. In case of absence of pregnancy after 4 IUI, couples will be treated by IVF. ART attempts will be performed according to usual procedures of each center. The follow-up will be ended either at the end of the first year of treatment if no pregnancy is obtained or at the time of delivery if a pregnancy is obtained. All data of attempts (demographics data, type and doses of treatment, adverse effects, outcome, number and health state of newborns....) will be recorded.

Conditions

Infertilities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

In Vitro Fecundation (IVF)

Couples will be treated by In Vitro Fecundation (IVF)

Group Type: EXPERIMENTAL

In Vitro Fecundation (IVF)

Intervention Type: PROCEDURE

In vivo fertilization will be performed according to the usual procedure of each Assisted Reproductive Technology (ART) center.

Intra Uterine Insemination (IUI)

Couples will be treated by Intra Uterine Insemination (IUI)

Group Type: ACTIVE_COMPARATOR

Intra Uterine Insemination (IUI)

Intervention Type: PROCEDURE

Intra-uterine insemination will be performed according to the usual procedure of each ART center

Interventions

In Vitro Fecundation (IVF)

In vivo fertilization will be performed according to the usual procedure of each Assisted Reproductive Technology (ART) center.

Intervention Type: PROCEDURE

Intra Uterine Insemination (IUI)

Intra-uterine insemination will be performed according to the usual procedure of each ART center

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Female age between 37 and 42 years at the time of inclusion
• Infertility duration ≥ 12 months
• Normal tubes
• No severe endometriosis
• At least 1.5 106 motile spermatozoa to be inseminated
• No previous ART attempt

Exclusion Criteria

• Tubal abnormalities
• Severe endometriosis
• Less than 1.5 106 motile spermatozoa to be inseminated
• Use of frozen sperm
• Presence of anti-spermatozoa antibodies

• Minimum Eligible Age: 37 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean PARINAUD, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Toulouse

Locations

University Hospital

Toulouse, Midi-Pyrénnées, France

CHU Bordeaux Hôpital Pellegrin

Bordeaux, , France

CHRU Brest Hôpital Morvan, service d'AMP

Brest, , France

Centre Hospitalier Intercommunal de Créteil, Service d'AMP

Créteil, , France

CHU Dijon Laboratoire de biologie de la reproduction

Dijon, , France

Institut de Médecine de la Reproduction

Marseille, , France

CHU Montpellier, Médecine de la Reproduction

Montpellier, , France

CHU Nantes centre d'AMP

Nantes, , France

CHU Nice centre d'AMP

Nice, , France

CHI Poissy St-Germain en Laye, centre d'AMP

Poissy, , France

Centre Hospitalier des Quatre Villes, Saint-Cloud Service de Médecine de la Reproduction

Saint-Cloud, , France

CHU de Strasbourg, Centre d'AMP

Strasbourg, , France

Countries

France

Other Identifiers

National PHRC 2012

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RC31/12/0553

Identifier Type: -

Identifier Source: org_study_id